Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in First-Line HPV-Negative Head and Neck Cancer
Reuters
Yesterday
<a href="https://laohu8.com/S/BCAX">Bicara Therapeutics</a> Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in First-Line HPV-Negative Head and Neck Cancer
Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS ≥1), excluding HPV-positive oropharyngeal squamous cell carcinoma. The designation is based on promising results from multiple Phase 1/1b cohorts, which demonstrated significant clinical benefit and a favorable safety profile. This regulatory milestone is intended to expedite the development and review of ficerafusp alfa, highlighting its potential to address an urgent unmet need in HPV-negative HNSCC. The grant was announced solely by Bicara Therapeutics Inc.
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